Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval.
Sign Up to like & getrecommendations! Published in 2019 at "JAMA internal medicine"
DOI: 10.1001/jamainternmed.2019.0462
Abstract: Importance The US Food and Drug Administration's (FDA's) accelerated approval pathway allows investigational cancer drugs to be approved by demonstrating a beneficial effect on a surrogate measure (eg, progression-free survival) that is expected to predict… read more here.
Keywords: clinical benefit; cancer drugs; confirmatory trials; accelerated approval ... See more keywords
Accelerated Approval Of Cancer Drugs: No Economic Reward For Drug Makers That Conduct Confirmatory Trials.
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DOI: 10.1377/hlthaff.2022.00119
Abstract: The Food and Drug Administration uses expedited approval of drugs to speed the development and assessment of drugs that address unmet needs related to serious or life-threatening conditions. Drugs approved via this route rely on… read more here.
Keywords: economic reward; approval; cancer drugs; drug ... See more keywords
Methods and Designs of Modern Breast Cancer Confirmatory Trials
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DOI: 10.3390/cancers13112757
Abstract: Simple Summary The benefit–risk assessments of new drugs for breast cancer (BC) face several challenges, as all stakeholders do not agree on the evidence bar required for market authorization, and by the fragmentation of breast… read more here.
Keywords: confirmatory trials; breast; breast cancer; methods designs ... See more keywords